Manufacturers/Fresenius Kabi USA, LLC

Fresenius Kabi USA, LLC

165 drugs in NADAC|157 Generic,8 Brand

View Recalls (50)

Fresenius Kabi USA, LLC lists 165 NDCs in the CMS NADAC file (157 generic, 8 brand), at an average NADAC of $24.59 per unit, with a week-over-week move of -0.4% across products that moved. The firm's full portfolio, pricing trend, and FDA recalls are listed below.

Total Drugs

165

157G / 8B

Avg Price / Unit

$24.5904

$0.03 – $872.80

Avg 7d Change

-0.42%

Across 94 drugs with changes

7d Activity

395571 flat

of 165 total drugs

Portfolio Price Trend

Monthly average NADAC price across all drugs

Frequently Asked Questions

How many drugs does Fresenius Kabi USA, LLC make?

Fresenius Kabi USA, LLC lists 165 NDCs in the CMS NADAC file — 157 generic and 8 brand products.

What is the average price of Fresenius Kabi USA, LLC drugs?

The average NADAC across Fresenius Kabi USA, LLC's portfolio is $24.5904 per unit, ranging from $0.0273 to $872.7967.

What types of drugs does Fresenius Kabi USA, LLC make?

Fresenius Kabi USA, LLC makes drugs across 53 FDA pharmacologic classes. The most common by NDC count are Low Molecular Weight Heparin (25), Antidote (9), Antidote for Acetaminophen Overdose (9), Mucolytic (9), Corticosteroid (9).

Has Fresenius Kabi USA, LLC had any drug recalls?

50 FDA recalls are matched to Fresenius Kabi USA, LLC in the openFDA feed, most recently on Jul 16, 2026.

How has Fresenius Kabi USA, LLC's pricing changed recently?

Over the past 7 days, 39 Fresenius Kabi USA, LLC products rose and 55 fell, with a portfolio-wide average change of -0.4%.

Drug Portfolio

165 drugs total, 165 shown

Drug Price 7d Change
ADALIMUMAB-AACF(CF) PEN 40 MG/0.8 ML (2 PACK)
adalimumab
$872.7967
per EA
-0.09%
TYENNE 162 MG/0.9 ML AUTOINJCT
Tocilizumab-aazg
$820.9968
per ML
+0.04%
TYENNE 162 MG/0.9 ML AUTOINJCT
Tocilizumab-aazg
$820.9968
per ML
+0.04%
CHORIONIC GONAD 10,000 UNIT VL
Chorionic Gonadotropin
$251.5842
per EA
+0.23%
GLUCAGON 1 MG EMERGENCY KIT
Glucagon
$239.2095
per EA
+0.64%
GANIRELIX ACET 250 MCG/0.5 ML
Ganirelix Acetate
$62.3467
per ML
BORTEZOMIB 3.5 MG VIAL
Bortezomib
$43.3460
per EA
OCTREOTIDE 1,000 MCG/ML VIAL
OCTREOTIDE ACETATE
$41.7580
per ML
VANCOMYCIN HCL 5 GM VIAL
VANCOMYCIN HYDROCHLORIDE
$39.3160
per EA
VANCOMYCIN HCL 5 GM VIAL
VANCOMYCIN HYDROCHLORIDE
$39.3160
per EA
FOSAPREPITANT 150 MG VIAL
FOSAPREPITANT
$38.5080
per EA
VANCOMYCIN HCL 10 GM VIAL
VANCOMYCIN HYDROCHLORIDE
$35.8586
per EA
VANCOMYCIN HCL 10 GM VIAL
VANCOMYCIN HYDROCHLORIDE
$35.8586
per EA
VORICONAZOLE 200 MG VIAL
Voriconazole
$28.7741
per EA
ERTAPENEM 1 GRAM VIAL
Ertapenem Sodium
$27.7551
per EA
-8.35%
BLEOMYCIN SULFATE 15 UNIT VIAL
BLEOMYCIN SULFATE
$26.4480
per EA
DAPTOMYCIN 500 MG VIAL
Daptomycin
$20.7686
per EA
DAPTOMYCIN 500 MG VIAL
Daptomycin
$20.7686
per EA
DESMOPRESSIN AC 4 MCG/ML VIAL
Desmopressin Acetate
$20.4409
per ML
-1.29%
DESMOPRESSIN 40 MCG/10 ML VIAL
Desmopressin Acetate
$20.4409
per ML
-1.29%
GEMCITABINE HCL 1 GRAM VIAL
GEMCITABINE
$19.9960
per EA
GEMCITABINE HCL 1 GRAM VIAL
GEMCITABINE
$19.9960
per EA
HALOPERIDOL DEC 100 MG/ML VIAL
HALOPERIDOL DECANOATE
$16.0162
per ML
-5.55%
HALOPERIDOL DEC 100 MG/ML VIAL
HALOPERIDOL DECANOATE
$16.0162
per ML
-5.55%
COLISTIMETHATE 150 MG VIAL
COLISTIMETHATE SODIUM
$15.4867
per EA
ENOXAPARIN 150 MG/ML SYRINGE
enoxaparin sodium
$15.3321
per ML
SUMATRIPTAN 6 MG/0.5 ML VIAL
Sumatriptan Succinate
$15.0000
per ML
ENOXAPARIN 120 MG/0.8 ML SYR
enoxaparin sodium
$14.8986
per ML
HALOPERIDOL DEC 500 MG/5 ML VL
HALOPERIDOL DECANOATE
$14.3235
per ML
+10.36%
HALOPERIDOL DEC 50 MG/ML VIAL
HALOPERIDOL DECANOATE
$12.4667
per ML
ENOXAPARIN 120 MG/0.8 ML SYR
Enoxaparin Sodium
$10.8924
per ML
-5.02%
FLUPHENAZINE DEC 125 MG/5 ML
FLUPHENAZINE DECANOATE
$10.8919
per ML
+6.46%
ENOXAPARIN 300 MG/3 ML VIAL
enoxaparin sodium
$10.2663
per ML
+3.39%
ENOXAPARIN 40 MG/0.4 ML SYR
enoxaparin sodium
$9.8516
per ML
ENOXAPARIN 30 MG/0.3 ML SYR
enoxaparin sodium
$9.6878
per ML
ENOXAPARIN 150 MG/ML SYRINGE
Enoxaparin Sodium
$9.6365
per ML
-5.71%
ENOXAPARIN 30 MG/0.3 ML SYR
Enoxaparin Sodium
$9.5904
per ML
-0.12%
ENOXAPARIN 30 MG/0.3 ML SYR
Enoxaparin Sodium
$9.5904
per ML
-0.12%
ENOXAPARIN 30 MG/0.3 ML SYR
enoxaparin sodium
$9.5904
per ML
-0.12%
ENOXAPARIN 80 MG/0.8 ML SYR
enoxaparin sodium
$9.3253
per ML
ENOXAPARIN 40 MG/0.4 ML SYR
Enoxaparin Sodium
$8.1253
per ML
+0.26%
ENOXAPARIN 40 MG/0.4 ML SYR
Enoxaparin Sodium
$8.1253
per ML
+0.26%
ENOXAPARIN 40 MG/0.4 ML SYR
enoxaparin sodium
$8.1253
per ML
+0.26%
ENOXAPARIN 60 MG/0.6 ML SYR
enoxaparin sodium
$7.6220
per ML
-2.50%
ENOXAPARIN 60 MG/0.6 ML SYR
Enoxaparin Sodium
$7.6220
per ML
-2.50%
ENOXAPARIN 60 MG/0.6 ML SYR
Enoxaparin Sodium
$7.6220
per ML
-2.50%
ENOXAPARIN 60 MG/0.6 ML SYR
enoxaparin sodium
$7.6220
per ML
-2.50%
HEPARIN SODIUM 20,000 UNIT/ML VIAL
HEPARIN SODIUM
$7.6218
per ML
CEFAZOLIN 10 GM VIAL
Cefazolin Sodium
$7.2930
per EA
ENOXAPARIN 80 MG/0.8 ML SYR
enoxaparin sodium
$6.7729
per ML
-1.58%
ENOXAPARIN 80 MG/0.8 ML SYR
Enoxaparin Sodium
$6.7729
per ML
-1.58%
ENOXAPARIN 80 MG/0.8 ML SYR
Enoxaparin Sodium
$6.7729
per ML
-1.58%
ENOXAPARIN 100 MG/ML SYRINGE
enoxaparin sodium
$6.5933
per ML
-4.59%
ENOXAPARIN 100 MG/ML SYRINGE
Enoxaparin Sodium
$6.5933
per ML
-4.59%
ENOXAPARIN 100 MG/ML SYRINGE
Enoxaparin Sodium
$6.5933
per ML
-4.59%
ENOXAPARIN 100 MG/ML SYRINGE
enoxaparin sodium
$6.5933
per ML
-4.59%
ACETYLCYSTEINE 6 GRAM/30 ML VL
Acetylcysteine
$6.1376
per ML
HEPARIN SODIUM 5,000 UNIT/0.5 ML SYRINGE
Heparin Sodium
$5.8995
per ML
EPHEDRINE SULFATE 50 MG/ML VL
Ephedrine Sulfate
$5.6366
per ML
CEFEPIME HCL 2 GRAM VIAL
Cefepime
$5.3480
per EA
OCTREOTIDE 1,000 MCG/5 ML VIAL
OCTREOTIDE ACETATE
$5.3404
per ML
ZOLEDRONIC ACID 4 MG/5 ML VIAL
Zoledronic Acid
$4.6828
per ML
MEROPENEM IV 1 GM VIAL
Meropenem
$4.6687
per EA
-3.51%
MEROPENEM IV 1 GM VIAL
Meropenem
$4.6687
per EA
-3.51%
CEFEPIME HCL 1 GM VIAL
Cefepime
$3.7308
per EA
METHYLPREDNISOLONE SS 125 MG
METHYLPREDNISOLONE SODIUM SUCCINATE
$3.5845
per EA
-9.20%
AZITHROMYCIN I.V. 500 MG VIAL
AZITHROMYCIN MONOHYDRATE
$3.5270
per EA
AZITHROMYCIN I.V. 500 MG VIAL
AZITHROMYCIN MONOHYDRATE
$3.5270
per EA
PIPERACIL-TAZOBACT 3.375 GM VL
Piperacillin and Tazobactam
$3.4926
per EA
PIPERACIL-TAZOBACT 3.375 GM VL
Piperacillin and Tazobactam
$3.4926
per EA
PIPERACIL-TAZOBACT 3.375 GM VL
Piperacillin and Tazobactam
$3.4926
per EA
HEPARIN SOD 5,000 UNIT/ML SYRG
Heparin Sodium
$3.3446
per ML
AMPICILLIN 2 GM VIAL
ampicillin sodium
$3.2338
per EA
METHOTREXATE 250 MG/10 ML VIAL
METHOTREXATE SODIUM
$3.1283
per ML
-3.66%
MEROPENEM IV 500 MG VIAL
Meropenem
$2.8678
per EA
MEROPENEM IV 500 MG VIAL
Meropenem
$2.8678
per EA
HYDROMORPHONE 2 MG/ML VIAL
Hydromorphone Hydrochloride
$2.7403
per ML
ACETYLCYSTEINE 10% VIAL (NOT FOR INJECTION)
ACETYLCYSTEINE
$2.6189
per ML
-0.92%
HYDROMORPHONE 50 MG/5 ML VIAL
Hydromorphone Hydrochloride
$2.5663
per ML
HYDROMORPHONE 500 MG/50 ML VL
Hydromorphone Hydrochloride
$2.5663
per ML
OCTREOTIDE ACET 100 MCG/ML VL
OCTREOTIDE ACETATE
$2.4097
per ML
-5.10%
OCTREOTIDE ACET 100 MCG/ML VL
OCTREOTIDE ACETATE
$2.4097
per ML
-5.10%
AMIKACIN SULF 500 MG/2 ML VIAL
Amikacin Sulfate
$2.2971
per ML
+1.38%
ACETYLCYSTEINE 20% VIAL (NOT FOR INJECTION)
ACETYLCYSTEINE
$2.1633
per ML
-3.00%
ACETYLCYSTEINE 20% VIAL (NOT FOR INJECTION)
ACETYLCYSTEINE
$2.1633
per ML
-3.00%
THIAMINE 200 MG/2 ML VIAL
THIAMINE HYDROCHLORIDE
$2.1624
per ML
-3.34%
THIAMINE 200 MG/2 ML VIAL
THIAMINE HYDROCHLORIDE
$2.1624
per ML
-3.34%
THIAMINE 200 MG/2 ML VIAL
THIAMINE HYDROCHLORIDE
$2.1624
per ML
-3.34%
LORAZEPAM 2 MG/ML VIAL
Lorazepam
$2.1170
per ML
+3.64%
HEPARIN SODIUM 10,000 UNIT/ML VIAL
HEPARIN SODIUM
$2.0958
per ML
-0.96%
HALOPERIDOL LAC 5 MG/ML VIAL
HALOPERIDOL LACTATE
$1.8983
per ML
PACLITAXEL 100 MG/16.7 ML VIAL
Paclitaxel
$1.8891
per ML
PACLITAXEL 300 MG/50 ML VIAL
Paclitaxel
$1.7700
per ML
FENTANYL 100 MCG/2 ML VIAL
Fentanyl Citrate
$1.7269
per ML
+9.06%
FENTANYL 2,500 MCG/50 ML VIAL
Fentanyl Citrate
$1.7269
per ML
+9.06%
KETAMINE 500 MG/5 ML VIAL
ketamine hydrochloride
$1.5436
per ML
CYANOCOBALAMIN 1,000 MCG/ML VL
CYANOCOBALAMIN
$1.4939
per ML
+1.06%
CYANOCOBALAMIN 1,000 MCG/ML VL
CYANOCOBALAMIN
$1.4939
per ML
+1.06%
GLYCOPYRROLATE 0.2 MG/ML VIAL
Glycopyrrolate
$1.4806
per ML
+6.24%
GLYCOPYRROLATE 0.2 MG/ML VIAL
Glycopyrrolate
$1.4806
per ML
+6.24%
GLYCOPYRROLATE 0.2 MG/ML VIAL
Glycopyrrolate
$1.4806
per ML
+6.24%
CEFTRIAXONE 1 GM VIAL
Ceftriaxone
$1.4427
per EA
+1.23%
PROGESTERONE 500 MG/10 ML VIAL
PROGESTERONE
$1.4354
per ML
-3.29%
GENTAMICIN 80 MG/2 ML VIAL
GENTAMICIN SULFATE
$1.3574
per ML
-0.78%
GENTAMICIN 80 MG/2 ML VIAL
GENTAMICIN SULFATE
$1.3574
per ML
-0.78%
ACETYLCYSTEINE 20% VIAL (NOT FOR INJECTION)
ACETYLCYSTEINE
$1.3184
per ML
DEXAMETHASONE 10 MG/ML VIAL
DEXAMETHASONE SODIUM PHOSPHATE
$1.2928
per ML
-10.70%
DEXAMETHASONE 10 MG/ML VIAL
DEXAMETHASONE SODIUM PHOSPHATE
$1.2928
per ML
-10.70%
FLUMAZENIL 0.5 MG/5 ML VIAL
FLUMAZENIL
$1.1791
per ML
+2.48%
HEPARIN SODIUM 5,000 UNIT/ML VIAL
HEPARIN SODIUM
$1.1719
per ML
-2.54%
HEPARIN SODIUM 5,000 UNIT/ML VIAL
HEPARIN SODIUM
$1.1719
per ML
-2.54%
HEPARIN SODIUM 5,000 UNIT/ML VIAL
HEPARIN SODIUM
$1.1719
per ML
-2.54%
KETOROLAC 30 MG/ML VIAL
KETOROLAC TROMETHAMINE
$1.0448
per ML
+3.89%
KETOROLAC 30 MG/ML VIAL
KETOROLAC TROMETHAMINE
$1.0448
per ML
+3.89%
KETOROLAC 30 MG/ML VIAL
KETOROLAC TROMETHAMINE
$1.0448
per ML
+3.89%
CEFAZOLIN 1 GM VIAL
CEFAZOLIN SODIUM
$1.0301
per EA
+2.32%
LIDOCAINE HCL 1% VIAL
LIDOCAINE HYDROCHLORIDE
$1.0206
per ML
ACETYLCYSTEINE 10% VIAL (NOT FOR INJECTION)
ACETYLCYSTEINE
$0.9656
per ML
KETOROLAC 15 MG/ML VIAL
KETOROLAC TROMETHAMINE
$0.9459
per ML
KETOROLAC 15 MG/ML VIAL
KETOROLAC TROMETHAMINE
$0.9459
per ML
KETOROLAC 15 MG/ML VIAL
KETOROLAC TROMETHAMINE
$0.9459
per ML
DIPHENHYDRAMINE 50 MG/ML VIAL
DIPHENHYDRAMINE HYDROCHLORIDE
$0.9336
per ML
-0.71%
DIPHENHYDRAMINE 50 MG/ML VIAL
DIPHENHYDRAMINE HYDROCHLORIDE
$0.9336
per ML
-0.71%
GENTAMICIN 40 MG/ML VIAL
GENTAMICIN SULFATE
$0.9335
per ML
HALOPERIDOL LAC 5 MG/ML VIAL
HALOPERIDOL LACTATE
$0.7890
per ML
-0.02%
ACETYLCYSTEINE 20% VIAL (NOT FOR INJECTION)
ACETYLCYSTEINE
$0.7413
per ML
-0.45%
ACETYLCYSTEINE 20% VIAL (NOT FOR INJECTION)
ACETYLCYSTEINE
$0.7413
per ML
-0.45%
TOBRAMYCIN 80 MG/2 ML VIAL
TOBRAMYCIN SULFATE
$0.7395
per ML
+13.76%
DEXAMETHASONE 120 MG/30 ML VL
DEXAMETHASONE SODIUM PHOSPHATE
$0.6943
per ML
+0.40%
DEXAMETHASONE 4 MG/ML VIAL
DEXAMETHASONE SODIUM PHOSPHATE
$0.6719
per ML
+2.19%
DEXAMETHASONE 4 MG/ML VIAL
DEXAMETHASONE SODIUM PHOSPHATE
$0.6719
per ML
+2.19%
ACETYLCYSTEINE 10% VIAL (NOT FOR INJECTION)
ACETYLCYSTEINE
$0.6351
per ML
-0.29%
KETAMINE 500 MG/10 ML VIAL
ketamine hydrochloride
$0.5579
per ML
+1.23%
DEXAMETHASONE 100 MG/10 ML VL
DEXAMETHASONE SODIUM PHOSPHATE
$0.5042
per ML
+0.41%
KETOROLAC 60 MG/2 ML VIAL
KETOROLAC TROMETHAMINE
$0.4980
per ML
+3.65%
KETOROLAC 60 MG/2 ML VIAL
KETOROLAC TROMETHAMINE
$0.4980
per ML
+3.65%
KETOROLAC 60 MG/2 ML VIAL
KETOROLAC TROMETHAMINE
$0.4980
per ML
+3.65%
ZOLEDRONIC ACID 5 MG/100 ML
Zoledronic Acid
$0.4774
per ML
-3.05%
FUROSEMIDE 20 MG/2 ML VIAL
FUROSEMIDE
$0.4616
per ML
+6.99%
FUROSEMIDE 20 MG/2 ML VIAL
FUROSEMIDE
$0.4616
per ML
+6.99%
MIDAZOLAM HCL 50 MG/10 ML VIAL
MIDAZOLAM HYDROCHLORIDE
$0.4500
per ML
ROCURONIUM 50 MG/5 ML VIAL
ROCURONIUM BROMIDE
$0.3942
per ML
ROCURONIUM 50 MG/5 ML VIAL
ROCURONIUM BROMIDE
$0.3942
per ML
ROCURONIUM 50 MG/5 ML VIAL
ROCURONIUM BROMIDE
$0.3942
per ML
ROCURONIUM 50 MG/5 ML VIAL
ROCURONIUM BROMIDE
$0.3942
per ML
TRANEXAMIC ACID 1,000 MG/10 ML
Tranexamic Acid
$0.3481
per ML
WATER FOR INJECTION VIAL
WATER
$0.3076
per ML
XYLOCAINE 1%-EPI 1:100,000
LIDOCAINE HYDROCHLORIDE,EPINEPHRINE BITARTRATE
$0.2721
per ML
XYLOCAINE 1%-EPI 1:100,000
LIDOCAINE HYDROCHLORIDE,EPINEPHRINE BITARTRATE
$0.2721
per ML
FUROSEMIDE 40 MG/4 ML VIAL
FUROSEMIDE
$0.2658
per ML
-6.32%
FUROSEMIDE 40 MG/4 ML VIAL
FUROSEMIDE
$0.2658
per ML
-6.32%
XYLOCAINE 2%-EPI 1:100,000
LIDOCAINE HYDROCHLORIDE,EPINEPHRINE BITARTRATE
$0.2655
per ML
DEXAMETHASONE 20 MG/5 ML VIAL
DEXAMETHASONE SODIUM PHOSPHATE
$0.2381
per ML
DEXAMETHASONE 20 MG/5 ML VIAL
DEXAMETHASONE SODIUM PHOSPHATE
$0.2381
per ML
MIDAZOLAM HCL 2 MG/2 ML VIAL
MIDAZOLAM HYDROCHLORIDE
$0.2343
per ML
+0.17%
ONDANSETRON HCL 4 MG/2 ML VIAL
ONDANSETRON HYDROCHLORIDE
$0.1771
per ML
-1.16%
ONDANSETRON HCL 4 MG/2 ML VIAL
ONDANSETRON HYDROCHLORIDE
$0.1771
per ML
-1.16%
ONDANSETRON 40 MG/20 ML VIAL
ONDANSETRON HYDROCHLORIDE
$0.1700
per ML
-1.64%
SODIUM BICARBONATE 8.4% VIAL
Sodium Bicarbonate
$0.1540
per ML
LIDOCAINE HCL 1% VIAL
LIDOCAINE HYDROCHLORIDE
$0.1378
per ML
+0.53%
SENSORCAINE 0.5% VIAL
BUPIVACAINE HYDROCHLORIDE
$0.0977
per ML
SODIUM CHLORIDE 0.9% VIAL
SODIUM CHLORIDE
$0.0883
per ML
+1.86%
WATER FOR INJECTION VIAL
WATER
$0.0661
per ML
SODIUM CHLORIDE 0.9% VIAL
SODIUM CHLORIDE
$0.0584
per ML
BACTERIOSTATIC SALINE VIAL
SODIUM CHLORIDE
$0.0273
per ML

FDA Recalls (50)

Recalls matched by company name. Verify current status with FDA.

D-0727-2026
Ongoing
Class II

Naropin (ropivacaine hydrochloride Injection, USP), 0.5%, 100 mg per 20 mL (5 mg per mL), Twenty-five, 20 mL Single-Dose Vials, Rx only, Fresenius Kabi, Lake Zurich, IL 60047 NDC Tray: 63323-286-23; NDC Vial: 63323-286-05

Presence of Particulate Matter: Hair was found in products

Initiated: 7/16/2026
D-0725-2026
Ongoing
Class II

Glycopyrrolate Injection, USP, 1 mg per 5 mL (0.2 mg per mL), 25 x 5 mL fill in a 6.5 mL vial, Rx only, Multiple Dose Vials, Fresenius Kabi, Lake Zurich, IL 60047 NDC Tray: 63323-578-05; NDC Vial: 63323-578-07

Presence of Particulate Matter: Hair was found in product

Initiated: 7/16/2026
D-0729-2026
Ongoing
Class II

Xylocaine (lidocaine HCl Injection, USP), 1%, 500 mg per 50 mL (10 mg per mL), 25 Multiple-Dose Vials, 50 mL, Rx only, Sterile, Fresenius Kabi, Lake Zurich, IL 60047 NDC Tray: 63323-485-57; NDC Vial: 63323-485-03

Presence of Particulate Matter: Hair was found in products

Initiated: 7/16/2026
D-0726-2026
Ongoing
Class II

Lidocaine HCl Injection, USP, 2%, 100 mg per 5 mL (20 mg per mL), 25 Single Dose Vials, 5 mL per vial, Rx only, Sterile, Fresenius Kabi, Lake Zurich, IL 60047 NDC Tray: 63323-208-05; NDC Vial: 63323-208-01

Presence of Particulate Matter: Hair was found in products

Initiated: 7/16/2026
D-0728-2026
Ongoing
Class II

Xylocaine (lidocaine HCl Injection, USP), 1%, 200 mg per 20 mL (10 mg per mL), 25 Multiple-Dose Vials, 20 mL, Rx only, Sterile, Fresenius Kabi, Lake Zurich, IL 60047 NDC Tray: 63323-485-27; NDC Vial: 63323-485-01

Presence of Particulate Matter: Hair was found in products

Initiated: 7/16/2026
D-0581-2026
Ongoing
Class III

Epinephrine Injection, USP, 1mg/mL, 1 mL single-dose vial, Rx only, Fresenius Kabi, Lake Zurich, IL 60047, NDC 63323-696-02 (vial), NDC 63323-696-25 (carton)

Failed Impurities/Degradations Specifications

Initiated: 5/14/2026
D-0424-2026
Ongoing
Class II

0.45% Sodium Chloride Injection, USP, 1.125 grams per 250 mL (4.5 mg per mL), 250 mL in a 250 mL freeflex bag, Rx only, Fresenius Kabi USA, LLC ("Fresenius Kabi"), Lake Zurich, IL 60047, Unit of Use NDC: 63323-626-03, Unit of Sale NDC Number: 63323-626-25 (30 bags in 1 case).

Lack of Assurance of Sterility

Initiated: 3/11/2026
D-0436-2026
Ongoing
Class II

5% Dextrose Injection, USP 5 g per 100 mL (50 mg per mL) 100 mL in a 100 mL freeflex bag, Fresenius Kabi USA, LLC ("Fresenius Kabi"), Unit of Use NDC: 65219-464-05, Unit of Sale NDC Number: 65219-464-50.

Lack of Assurance of Sterility

Initiated: 3/11/2026
D-0437-2026
Ongoing
Class II

5% Dextrose Injection, USP 12.5 g per 250 mL (50 mg per mL) 250 mL in a 250 mL freeflex bag, Fresenius Kabi USA, LLC ("Fresenius Kabi"), Unit of Use NDC: 65219-458-05, Unit of Sale NDC Number: 65219-458-30.

Lack of Assurance of Sterility

Initiated: 3/11/2026
D-0435-2026
Ongoing
Class II

5% Dextrose Injection, USP 2.5 g per 50 mL (50 mg per mL) 50 mL in a 100 mL freeflex bag, Fresenius Kabi USA, LLC ("Fresenius Kabi"), Unit of Use NDC: 65219-456-05, Unit of Sale NDC Number: 65219-456-60.

Lack of Assurance of Sterility

Initiated: 3/11/2026
D-0430-2026
Ongoing
Class II

0.9% Sodium Chloride Injection, USP, 900 mg per 100 mL (9 mg per mL) 100 mL in a Single Dose freeflex bag, Rx only, BD Beckton, Dickson and Company, 1 Beckton Drive, Franklin Lakes, NJ 07417 USA, Distributed by BD, Manufactured by: Fresenius Kabi USA, LLC ("Fresenius Kabi"), Unit of Sale NDC Number: 17271-701-03.

Lack of Assurance of Sterility

Initiated: 3/11/2026
D-0428-2026
Ongoing
Class II

0.9% Sodium Chloride Injection, USP, (4,500 mg per 500 mL) (9 mg per mL) 500 mL in a 500 mL freeflex bag, Rx only, Fresenius Kabi USA, LLC ("Fresenius Kabi"), Lake Zurich, IL 60047, Unit of Use NDC: 65219-472-05, Unit of Sale NDC Number: 65219-472-20.

Lack of Assurance of Sterility

Initiated: 3/11/2026
D-0426-2026
Ongoing
Class II

0.9% Sodium Chloride Injection, USP, 0.9% (900 mg per 100 mL) (9 mg per mL) 100 mL in a 100 mL freeflex bag, Rx only, Fresenius Kabi USA, LLC ("Fresenius Kabi"), Lake Zurich, IL 600047, Unit of Use NDC: 65219-468-05, Unit of Sale NDC Number: 65219-468-50.

Lack of Assurance of Sterility

Initiated: 3/11/2026
D-0432-2026
Ongoing
Class II

0.9% Sodium Chloride Injection, USP 900 mg per 100 mL (9 mg per mL) 500 mL in a Single Dose freeflex bag, 500 mL x 20, Manufactured for: Fresenius Kabi USA, LLC ("Fresenius Kabi"), IL 60047, Unit of Use NDC: 65219-432-20, Unit of Sale NDC Number: 65219-432-85.

Lack of Assurance of Sterility

Initiated: 3/11/2026
D-0434-2026
Ongoing
Class II

0.9% Sodium Chloride Injection, USP 900 mg per 100 mL (9 mg per mL), 1,000 mL in a Single Dose freeflex bag, Rx only, BD Becton, Dickson and Company, 1 Becton Drive, Franklin Lakes, NJ 07417, Distributed by BD, Manufactured by Fresenius Kabi, Unit of Sale NDC Number: 17271-701-07.

Lack of Assurance of Sterility

Initiated: 3/11/2026
D-0431-2026
Ongoing
Class II

0.9% Sodium Chloride Injection, USP, 900 mg per 100 mL (9 mg per mL) 250 mL in a Single Dose freeflex bag, Rx only, BD Becton, Dickson and Company, 1 Beckton Drive, Franklin Lakes, NJ 07417, Distributed by BD, Manufactured by: Fresenius Kabi USA, LLC ("Fresenius Kabi"), Unit of Sale NDC Number: 17271-701-05.

Lack of Assurance of Sterility

Initiated: 3/11/2026
D-0429-2026
Ongoing
Class II

0.9% Sodium Chloride Injection, USP, 50 mL x60, Becton, Dickson and Company, 1 Beckton Drive, Franklin Lakes, NJ 07417 USA, Distributed by BD, Manufactured by Fresenius Kabi USA, LLC ("Fresenius Kabi"), Unit of Sale NDC Number: 17271-701-02.

Lack of Assurance of Sterility

Initiated: 3/11/2026
D-0425-2026
Ongoing
Class II

0.9% Sodium Chloride Injection, USP 0.9% (450 mg per 50 mL) (9 mg per mL) 50 mL, Rx only, Fresenius Kabi USA, LLC ("Fresenius Kabi"), Lake Zurich, IL 60047, Unit of Use NDC: 65219-466-05, Unit of Sale NDC Number: 65219-466-60.

Lack of Assurance of Sterility

Initiated: 3/11/2026
D-0433-2026
Ongoing
Class II

0.9% Sodium Chloride Injection, USP, 900 mg per 100 mL (9 mg per mL) 1,000 mL in a Single Dose freeflex bag, 1,000 mLx10, Fresenius Medical Care, Waltham, MA 02451, Distributed by: Fresenius Medical Care RTG, LLC, Manufactured by: Fresenius Kabi, Unit of Use NDC: 65219-282-01, Unit of Sale NDC Number: 65219-282-10.

Lack of Assurance of Sterility

Initiated: 3/11/2026
D-0427-2026
Ongoing
Class II

0.9% Sodium Chloride Injection, USP, (2,250 mg per 250 mL) (9 mg per mL) 250 mL in a 250 mL freeflex bag, Rx only, Fresenius Kabi USA, LLC ("Fresenius Kabi"), Lake Zurich, IL 60047, Unit of Use NDC: 65219-470-05, Unit of Sale NDC Number: 65219-470-30.

Lack of Assurance of Sterility

Initiated: 3/11/2026
D-0182-2026
Ongoing
Class I

Famotidine Injection, USP, 20 mg per 2 mL (10 mg per mL), 2 mL vials, Rx only, Fresenius Kabi USA, LLC, NDC 63323-739-11 (unit of use), 63323-739-12 (unit of sale).

Microbial Contamination of Sterile Products; out of limit results obtained for endotoxin testing.

Initiated: 11/6/2025
D-0129-2023
Terminated
Class II

Sensorcaine-MPF (Bupivacaine HCl and Epinephrine Injection, USP) with Epinephrine 1:200,000 (as bitartrate), 0.25%, 25 mg per 10 mL (2.5 mg per mL), 10 mL Single Dose Vial (NDC 63323-468-01), packaged in 25 Single Dose Vials per tray (NDC 63323-468-17), Rx only, Fresenius Kabi, Lake Zurich, IL 60047.

Subpotent Drug: Testing results below the defined limit for the epinephrine portion of this product.

Initiated: 11/22/2022
D-0127-2023
Terminated
Class II

Sensorcaine (Bupivacaine HCl and Epinephrine Injection, USP) with Epinephrine 1:200,000 (as bitartrate), 0.25%, 125 mg per 50 mL (2.5 mg per mL), 50 mL Multiple Dose Vial (NDC 63323-461-01), packaged in 25 Multiple Dose Vials per tray (NDC 63323-461-57), Rx only, Fresenius Kabi, Lake Zurich, IL 60047.

Subpotent Drug: Testing results below the defined limit for the epinephrine portion of this product.

Initiated: 11/22/2022
D-0128-2023
Terminated
Class II

Sensorcaine (Bupivacaine HCl and Epinephrine Injection, USP) with Epinephrine 1:200,000 (as bitartrate), 0.5%, 250 mg per 50 mL (5 mg per mL), 50 mL Multiple Dose Vial (NDC 63323-463-01), packaged in 25 Multiple Dose Vials per tray (NDC 63323-463-57), Rx only, Fresenius Kabi, Lake Zurich, IL 60047.

Subpotent Drug: Testing results below the defined limit for the epinephrine portion of this product.

Initiated: 11/22/2022
D-0750-2022
Terminated
Class I

Sodium Acetate Injection, USP, 400 mEq / 100 mL (4 mEq / mL), packaged in 2 trays of 20 vials per shipper (NDC 63323-032-00), each vial: 100 mL fill in a 100 mL vial (NDC 63323-032-04), Rx Only, Fresenius Kabi, Lake Zurich, IL 60047

Presence of particulate matter: particulates composed of carbon and oxygen with varying amounts of iron and trace amounts of sodium, silicon, chromium, aluminum and cellulose.

Initiated: 3/4/2022
D-0245-2021
Terminated
Class I

Ketorolac Tromethamine Injection, USP, 30 mg per mL, packaged in 1 mL Single Dose Vials (NDC 63323-162-00); 25 x 1 mL Single Dose Vials per tray (NDC 63323-162-01); For IM or IV use, Rx only, Fresenius Kabi, Lake Zurich, IL 60047.

Presence of Particulate Matter - found in reserve sample vials at the firm.

Initiated: 12/23/2020
D-0184-2021
Terminated
Class II

Ketorolac Tromethamine Injection, USP, 60 mg per 2 mL (30 mg per mL), packaged in 2 mL Single Dose Vial, Rx only, Fresenius Kabi, Lake Zurich, IL 60047, NDC 63323-162-02

Presence of Particulate Matter - found in reserve sample vials at the firm.

Initiated: 12/17/2020
D-0172-2021
Terminated
Class II

Sensorcaine-MPF (Bupivacaine HCl and Epinephrine Injection, USP), 0.5%, 150 mg per 30 mL (5 mg per mL), 30 mL Single Dose Vial (NDC 63323-462-01), packaged as 25 Single Dose Vials per tray (NDC 63323-462-37), Rx only, Fresenius Kabi, Lake Zurich, IL 60047.

Subpotent Drug: Low out-of-specification assay results for the epinephrine component.

Initiated: 12/10/2020
D-0120-2021
Terminated
Class I

Dexmedetomidine HCl in 0.9% Sodium Chloride Injection, 200 mcg / 50 mL (4 mcg / mL), 50 mL Single Dose Bottle, Rx only, Fresenius Kabi, Lake Zurich, IL 60047, NDC 63323-671-05

Cross Contamination with other products: trace amounts of lidocaine

Initiated: 11/17/2020
D-0105-2021
Terminated
Class III

DOXOrubicin Hydrochloride Injection, USP, 10 mg / 5 mL (2 mg / mL), 5 mL fill in a 6 mL vial, Single Dose Vial, Rx only, Sterile, Fresenius Kabi, Lake Zurich, IL 60047. NDC: 63323-883-05

Cross Contamination with Other Products: trace amounts of octreotide found during testing

Initiated: 11/17/2020
D-1537-2020
Terminated
Class I

Dexmedetomidine HCl in 0.9% Sodium Chloride Injection, 200 mcg per 50 mL (4 mcg per mL), for intravenous infusion, preservative free, 50 mL Single Dose Bottle, Rx only, Fresenius Kabi Lake Zurich, IL 60047, NDC 63323-671-05

Cross Contamination with other products: trace amounts of lidocaine

Initiated: 7/22/2020
D-1391-2020
Terminated
Class III

Fosaprepitant for Injection, 150 mg / vial in a 10 mL Single-Dose vial, Rx only, Fresenius Kabi, Lake Zurich, IL 60047; NDC 63323-972-10

Labeling Error: Label Error on Declared Strength: Carton label and product insert incorrectly states the quantity of the excipient edetate disodium (EDTA) as 5.4 mg / vial, rather than the actual amount of 18.8 mg / vial.

Initiated: 7/13/2020
D-1296-2020
Terminated
Class I

Ketorolac Tromethamine Injection, USP, 30 mg per mL, packaged in 1 mL Single Dose Vials (NDC 63323-162-00); 25 x 1 mL Single Dose Vials per tray (NDC 63323-162-01); For IM or IV use, Rx only, Fresenius Kabi, Lake Zurich, IL 60047.

Presence of Particulate Matter - found in reserve sample vials at the firm.

Initiated: 4/20/2020
D-1297-2020
Terminated
Class II

Ketorolac Tromethamine Injection, USP, 60 mg per 2 mL (30 mg per mL), packaged in 2 mL Single Dose Vials (NDC 63323-162-03), 25 x 2 mL Single Dose Vials per tray (NDC 63323-162-02); For IM use only, Not for IV use, Rx only, Fresenius Kabi, Lake Zurich, IL 60047.

Presence of Particulate Matter - found in reserve sample vials at the firm.

Initiated: 4/20/2020
D-1489-2019
Terminated
Class I

Fluorouracil Injection, USP, 5 g / 100 mL (50 mg / mL), 100 mL fill in a 100 mL vial, Rx Only, Mfd. by: Fresenius Kabi, Lake Zurich, IL 60047. 63323-117-61 [Fresenius Kabi brand] and NDC 63323-117-69 [NOVAPLUS brand]

Presence of Particulate Matter; glass particulates

Initiated: 6/28/2019
D-1386-2019
Terminated
Class III

Ondansetron Injection, USP, 40 mg / 20 mL, 20 mL vial, Rx Only, Fresenius Kabi USA, LLC, Lake Zurich, IL 60047, NDC 63323-374-20

Failed Impurities/Degradation Specifications.

Initiated: 5/22/2019
D-0298-2019
Terminated
Class I

SODIUM CHLORIDE INJECTION, USP, 0.9%, 10 mL Single Dose Vial, packaged in a 25-unit tray, Rx Only, APP Pharmaceuticals, LLC Schaumburg, IL 60173. NDC 63323-186-10 Product code 918610

Labeling Not Elsewhere Classified: Fresenius Kabi is taking this action due to an incorrect statement on the product insert for product codes 918610 and 918620 indicating that the stoppers do not contain natural rubber latex. The tray label for these two product codes and the vial label for product code 918620 also incorrectly state that the stoppers do not contain latex. The above listed product codes and batches being recalled have stoppers containing natural rubber latex.

Initiated: 11/15/2018
D-0299-2019
Terminated
Class I

SODIUM CHLORIDE INJECTION, USP, 0.9%, 20 mL Single Dose Vial, packaged in a 25-unit tray, Rx Only, APP Pharmaceuticals, LLC Schaumburg, IL 60173. NDC 63323-186-20, Product code 918620

Labeling Not Elsewhere Classified: Fresenius Kabi is taking this action due to an incorrect statement on the product insert for product codes 918610 and 918620 indicating that the stoppers do not contain natural rubber latex. The tray label for these two product codes and the vial label for product code 918620 also incorrectly state that the stoppers do not contain latex. The above listed product codes and batches being recalled have stoppers containing natural rubber latex.

Initiated: 11/15/2018
D-0426-2018
Terminated
Class III

Vecuronium bromide for Injection, 10 mg vials, Rx only, Mfd. for: Fresenius Kabi, Lake Zurich, IL 60047, Made in India, NDC 63323-781-10

Failed impurities/ degradation specifications: Out-of-specification (OOS) result for USP related compound F at the 12 month stability test station.

Initiated: 1/16/2018
D-0152-2018
Terminated
Class I

Midazolam Injection, USP, Preservative Free, 2 mg / 2 mL (1 mg / mL), 24 X 2mL Prefilled single-use syringes per carton, Rx only, Fresenius Kabi Lake Zurich, IL 60047, NDC 76045-001-20

Labeling: Label MIX-UP. Blister Packages, Labeled as Midazolam injection, USP, 2 mg / 2 ml, Containing Syringes of Ondansetron Injection, USP, 4 mg / 2 mL

Initiated: 10/27/2017
D-0647-2017
Terminated
Class III

Fluphenazine Decanoate Injection, USP; 25 mg/mL, 5mL vials, Rx only, APP Pharmaceuticals, LLC Schaumburg, IL 60173, NDC 63323-0272-05

Subpotent Drug

Initiated: 3/16/2017
D-0456-2017
Terminated
Class II

MIDAZOLAM INJECTION, USP, *25 mg/5 mL, (5 mg/ mL), 5 mL vials, 10 Vials per carton, Rx only, APP Pharmaceuticals, LLC Schaumburg, IL 60173 --- NDC 63323-412-05

Failed Impurities/Degradation Specifications

Initiated: 12/16/2016
D-0867-2016
Terminated
Class II

OCTREOTIDE ACETATE INJECTION, 50 mcg (base)/mL (0.05 mg/mL), 1 mL Single Dose Vial, Rx only, Manufactured by Fresenius Kabi USA, LLC, Schaumburg, IL 60173, NDC 63323-365-04

Failed Impuities/Degradation Specifications

Initiated: 5/4/2016
D-0866-2016
Terminated
Class II

OCTREOTIDE ACETATE INJECTION, 50 mcg (base)/mL (0.05 mg/mL), 1 mL Single Dose Vial, Rx only, Manufactured by Fresenius Kabi USA, LLC, Schaumburg, IL 60173, NDC 63323-365-01.

Failed Impuities/Degradation Specifications

Initiated: 5/4/2016
D-1037-2016
Terminated
Class II

Sensorcaine- MPF (Bupivacaine HCI Injection, USP), 0.75% in a 30 mL Single Dose Vial, Rx only, Fresenius Kabi USA LLC, Lake Zurich, IL 60047, NDC 63323-472-37

Presence of Particulate Matter: Glass particulate found in sterile injectable product

Initiated: 4/25/2016
D-0818-2016
Terminated
Class III

Haloperidol Decanoate Injection, 50 mg/mL, 1 mL vial, Rx Only. Fresenius Kabi USA LLC, Lake Zurich, IL 60047, NDC 63323-469-01.

Failed Impurities/Degradation Specifications: Firm is recalling product due to an impurity out-of-specification result.

Initiated: 4/7/2016
D-0819-2016
Terminated
Class II

Cisatracurium Besylate Injection, 20 mg per 10 mL (2 mg per mL), For intravenous injection, 10 mL Multiple Dose Vial, Rx only, Fresenius Kabi USA, LLC Lake Zurich, IL 60047, NDC 63323-417-10

Incorrect/ Undeclared Excipient: Firm is recalling product due to an incorrect statement of Preservative free on the individual carton label. The vial label and outer carton label contain the correct statement of 0.9% benzyl alcohol added as a preservative.

Initiated: 4/5/2016
D-1327-2015
Terminated
Class III

Hydralazine Hydrochloride Injection, USP, 20 mg/mL, 1 mL fill, in a 2 mL; single dose vial. Manufactured by Fresenius Kabi USA 2020 N Ruby Street, Melrose Park, IL 60160-1112 for Fresenius Kabi USA, 3 Corporate Dr Lake Zurich, IL 60047-8930. NDC 63323-614-01

Incorrect Expiration Date: The "11/06" expiration date printed on the tray (secondary packaging) is incorrect (it should be 11/2016)

Initiated: 7/28/2015
D-1234-2015
Terminated
Class II

Rifampin for Injection, USP 600mg/vial in a 20mL vial, Rx only, Manufactured for Fresenius Kabi LLC 3 Corporate Drive, Lake Zurich, IL, 60047, by Fresenius Kabi LLC, 2020 N Ruby Street, Melrose Park, IL 60160. NDC 63323-351-20

Failed Impurities/Degradation Specifications; out-of-specification for color, impurity, and degradation

Initiated: 6/4/2015
D-1114-2015
Terminated
Class II

KABIVEN [(3.9%) Lipid Injectable Emulsion with (3.1%) Amino Acids and Electrolytes and (9.8%) Dextrose; Sulfite-free], Rx Only. Manufactured by: FRESENIUS KABI Uppsala, Sweden. Packaged in 1) 1,540 mL Bags, NDC: 63323-712-15, and 2) 2,053 mL Bags, NDC: 63323-712-20.

Labeling: Label Error on Declared Strength: Labeled 3.1% Amino Acids but contains 3.3% Amino Acids

Initiated: 4/28/2015